UnknownPhase 3

A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding

Taiwan62 participantsStarted 2012-10

Plain-language summary

Though histoacryl injection is now regarded as treatment of choice in the control of gastric variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.

Who can participate

Age range20 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1.The etiology of portal hypertension is cirrhosis. 2.Age ranges between 20-80 y/o. 3.Patients presenting with history of gastric variceal bleeding or acute gastric variceal bleeding proven by emergency endoscopy Exclusion Criteria: * 1\) association with severe systemic illness, such as sepsis, CVA, COPD, advanced carcinoma, hepatocellular carcinoma (Barcelona Club Liver Cancer class C or D) 2) presence of massive ascites 3), serum creatinine \>3mg/dl, hepatic encephalopathy \> stage II, 4) serum bilirubin \> 10mg/dl 5) life expectancy less than 24 hours 6) Child-Pugh's scores \> 13 7) pregnancy 8) has ulcers on gastric varices 9) Uncooperative

What they're measuring

Ulcer on gastric varices

Timeframe: 1 month after therapy

Trial details

NCT IDNCT01717612

SponsorNational Science and Technology Council, Taiwan

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2016-04